The FDA grants 510(k) clearance to Boston Scientific’s (BSX +0.7%) EXALT Model D, a single-use duodenoscope (a hollow lighted tube for inspecting the small intestine) for use in endoscopic retrograde cholangiopancreatography procedures (aimed at diagnosing issues in the liver, gallbladder, bile ducts and pancreas).
The company says it is the first such single-use device available in the U.S. (other duodenoscopes are reusable which carries an infection risk if not cleaned thoroughly).
Limited commercial launch will commence next quarter.
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